Sr Principal Quality Engineer

4 weeks ago

Scottsdale, United States West Pharmaceutical Services Full time

Job Summary

:

Maintain a safe work environment and ensure compliance with quality objectives and policies. Work with business leads to develop, implement, and maintain programs and enhance solutions for customer base. Provide quality assurance support to all functions with focus on compliance in accordance with ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR) requirements. This role will support the execution of high complexity/impact projects that will impact the Quality of the product and a Compliance improvement significantly throughout the implementation of changes involving supplier related items, validation process, Quality Culture, risk management process improvement, change management, material controls improvement and Quality Control items.

Essential Duties and Responsibilities:

Interface with internal constituents and external regulatory bodies regarding compliance needs as required Assist in the preparation of the Management Review meeting presentations on a quarterly basis. Attend project team meetings on a regular basis and provide assistance with validation and regulatory strategies for various projects. May review and approve Complaint, CAPA, Audit Findings, Issue Reviews, Non-conformances investigations to provide guidance to ensure effective investigations are completed. Prepare Validation Strategies and executes accordingly by writing technical reports as needed. May create and execute validation protocols such as IQs, OQs, PQs, and/or TMVs. Supports the site with statistical techniques guidance to ensure compliance at the different departments during design transfer process, sampling plan implementations or improvements, establishments of CTQs, Validation strategies, and investigations as required. Provide continued quality system support by improving processes and systems and by updating and creating site procedures or enterprise procedures, Inspection requirements, Test Method inspections, etc. Participate in third party (Notified Body, FDA, Customer) audits as required: Back room lead, SME, Reviewer, etc. May manage key quality system programs such as CAPA, Quality Culture initiatives, Non-conformance or other QMS elements programs that are to be monitored and under control. Provide support to manufacturing lines to address issues and escalate issues to NC or CAPA process as needed. May work with high-risk investigation to document Quality Issues resolutions involved with internal issues or customer and external regulatory bodies through CAPA, SCAR, NCR, Issue Review, External Audit findings (Regulatory bodies: FDA, DEKRA, SGS) to ensure proper and robust actions are taken to eliminate re-occurrence. May supervise exempt and non-exempt personnel as required. Provide guidance, coaching, and train other Quality Engineers in Engineering topics such as Validation process, Root Cause Analysis, Statistical techniques, SPC, CAPA, NCRs, etc. Escalate Quality issues to upper management based on risk, trend, and compliance assessment. Ensure Site Metrics are complying with internal requirements and goals established. Work with high-complexity projects to ensure a process continuous improvement is in place. Create high-complexity Projects strategies and ensures execution is completed in a timely manner. Drives activities to reinforce Quality Culture through Quality initiatives, or processes related. May provide coaching to engineers/auditors to promote people development and process improvement culture. Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules. Exhibits regular, reliable, punctual, and predictable attendance . Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, quality culture reinforcement, and eliminate waste. Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards. Maintains a clean, orderly, and safe workstation and environment always. Performs other duties as assigned based on business needs.

Basic Qualifications:  

Education or Equivalent Experience: Engineering Bachelor’s Degree or equivalent Experience: 8-10yrs Quality Engineering Experience Validation Process knowledge Medical Device Regulations and standards (ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR) Project Management

  • Lead Principal Software Engineer

    1 week ago

    Scottsdale, Arizona, United States PayPal Full time

    Overview of the RoleAs a Lead Principal Software Engineer, you will serve as a key authority in your field. We seek individuals with exceptional technical expertise, programming acumen, and strong communication skills, coupled with a genuine interest in comprehensively understanding our offerings and enhancing the robustness and resilience of our...

  • Senior Principal Quality Assurance Engineer

    1 week ago

    Scottsdale, Arizona, United States West Pharmaceutical Services Full time

    Job Overview Ensure a secure working environment while adhering to quality standards and policies. Collaborate with business leaders to design, implement, and sustain programs that enhance solutions for the customer base. Deliver quality assurance support across all functions, emphasizing compliance with ISO 13485, ISO 14791, 21 CFR 820, and 2017/745...

  • Senior Principal Quality Assurance Engineer

    3 days ago

    Scottsdale, Arizona, United States West Pharmaceutical Services Full time

    Job OverviewEnsure a secure working environment while upholding quality standards and regulations. Collaborate with business leaders to design, implement, and sustain programs that enhance solutions for our clientele. Provide quality assurance support across all departments, focusing on compliance with ISO 13485, ISO 14791, 21 CFR 820, and 2017/745 (EU/MDR)...

  • Senior Principal Quality Assurance Engineer

    1 week ago

    Scottsdale, Arizona, United States West Pharmaceutical Services Full time

    Job Overview Ensure a secure working environment while adhering to quality standards and regulations. Collaborate with business leaders to design, implement, and sustain programs that enhance solutions for our clientele. Deliver quality assurance support across all departments with an emphasis on compliance aligned with ISO 13485, ISO 14791, 21 CFR 820,...

  • Principal Software Engineer/Architect

    2 months ago

    Scottsdale, United States Staffing Science Full time

    Our client in Scottsdale AZworks hybrid on site, so must be local and willing to go into an office 3 days per week.We are seeking a dynamic Lead/Staff Engineer/Architect to join our team. This role is a blend of engineering and architectural responsibilities, emphasizing the importance of technical leadership and strategic vision. Experience in the...

  • Principal Software Engineer/Architect

    2 months ago

    Scottsdale, United States Staffing Science Full time

    Our client in Scottsdale AZworks hybrid on site, so must be local and willing to go into an office 3 days per week.We are seeking a dynamic Lead/Staff Engineer/Architect to join our team. This role is a blend of engineering and architectural responsibilities, emphasizing the importance of technical leadership and strategic vision. Experience in the...

  • Sr Information Security Engineer

    2 months ago

    Scottsdale, United States Irvine Technology Corporation Full time

    Job DescriptionJob DescriptionSr. Information Security Engineer (Hybrid)We have an immediate need for a Sr. Information Security Engineer to join a national retailer for a contract position that is hybrid. The Sr. Information Security Engineer serves as a senior technical engineer and advisor to large complex system, application, or network...

  • Principal Staff Software Engineer

    5 days ago

    Scottsdale, United States DYPER Full time

     PRINCIPAL STAFF SOFTWARE ENGINEER - SEEKING LOCAL CANDIDATES FOR HYBRID ROLEAre you passionate about crafting exceptional digital experiences? Do you thrive at the intersection of cutting-edge technology and customer satisfaction? Join us at DYPER, where we are revolutionizing the way parents care for their little ones through sustainable, eco-friendly...

  • Sr Cloud Platform Engineer

    2 weeks ago

    Scottsdale, United States Insight Global Full time

    Role: Sr Cloud Platform Engineer Location: hybrid 3 days onsite in Scottsdale, AZType: Perm direct hire Pay: $143,000/yr Must haves:· Minimum of 7 years of progressive experience in IT infrastructure engineering, software development, information systems, or equivalent technical fields including previous experience in the development and support of highly...

  • Sr Cloud Platform Engineer

    2 weeks ago

    Scottsdale, United States Insight Global Full time

    Role: Sr Cloud Platform Engineer Location: hybrid 3 days onsite in Scottsdale, AZType: Perm direct hire Pay: $143,000/yr Must haves:· Minimum of 7 years of progressive experience in IT infrastructure engineering, software development, information systems, or equivalent technical fields including previous experience in the development and support of highly...

  • Principal REACT Software Engineer

    3 months ago

    Scottsdale, United States RiverPoint Full time

    Job DescriptionJob DescriptionPrincipal Software Engineer – REACT Infomatics is partnered is a large retailer that is hiring a Principal REACT Software Engineer on a direct/FTE basis in the Phoenix area. All applicants must be eligible and willing to be hiring directly on W2 without sponsorship. No C2C. Must possess good tenure with previous employers. No...

  • Sr. Information Security Engineer

    2 weeks ago

    Scottsdale, United States IMPACT Technology Recruiting Full time

    Our client, located in AZ is looking for a Sr. IT Security Engineer on a Contract basis.Note:2-3 days onsite/remote per week in Scottsdale, AZThis is a contract roleOpen to W2 or Corp to CorpRequired skillsAt least 5+ years progressively responsible information technology experience. At least 5+ years hands-on experience with security tools including, but...

  • Sr. Information Security Engineer

    2 weeks ago

    Scottsdale, United States IMPACT Technology Recruiting Full time

    Our client, located in AZ is looking for a Sr. IT Security Engineer on a Contract basis.Note:2-3 days onsite/remote per week in Scottsdale, AZThis is a contract roleOpen to W2 or Corp to CorpRequired skillsAt least 5+ years progressively responsible information technology experience. At least 5+ years hands-on experience with security tools including, but...

  • Sr. Software Manager

    3 weeks ago

    Scottsdale, United States Savas Health Full time

    Job DescriptionJob DescriptionSalary: from $140,000Our StorySavas (pronounced sah-vus) is a derivative of the word Seva (pronounced say-va), which means an act of selfless service and compassionate care. At Savas Health we strive every day to live up to that definition by providing the best care possible for our complex patient population. Our team of...

  • Sr. Solutions Engineer

    1 month ago

    Scottsdale, United States Foresight Intelligence Full time

    Job DescriptionJob DescriptionForesight Intelligence is a privately held, self-funded and rapidly growing entrepreneurial data company. Foresight is focused on streamlining data + revolutionizing industries such as construction, agriculture and beyond. We thrive on creativity, problem-solving and continuous improvement! It’s an exciting time of immense...

  • Analyst,Accounting,Sr

    3 weeks ago

    Scottsdale, United States Axelon Full time

    100% remote - anywhere in the U.S. Potential to extend Flexible 6am-9am AZ Time, 8 hour workday M-F No OT anticipated Description: Performs a variety of routine and some non-routine analysis functions in accordance with standard procedures in general accounting, accounts payable or accounts receivable or other financial department. Responsible for...

  • Analyst,Accounting,Sr

    4 weeks ago

    Scottsdale, United States Axelon Full time

    100% remote - anywhere in the U.S. Potential to extend Flexible 6am-9am AZ Time, 8 hour workday M-F No OT anticipated Description: Performs a variety of routine and some non-routine analysis functions in accordance with standard procedures in general accounting, accounts payable or accounts receivable or other financial department. Responsible for process...

  • SDA GMI Network Engineer

    3 months ago

    Scottsdale, United States General Dynamics Full time

    Basic Qualifications Requires a Bachelor’s degree in Systems Engineering, or a related Science, Engineering or Mathematics field. Also requires 10+ years of job-related experience, or a Master's degree plus 8 years of job-related experience. Agile experience preferred. CLEARANCE REQUIREMENTS: Department of Defense Secret security clearance...

  • Sr. Advanced Systems Engineer

    1 month ago

    Scottsdale, United States Softworld Inc Full time

    Job Title: Sr. Advanced Systems Engineer Job Location: Scottsdale AZ 85257 Onsite Requirements: Satellite Communications Ground to Satellite communication knowledge Job Description: As a Systems Engineer, you'll participate in requirements analysis and management, functional analysis, performance analysis, system design, trade studies, systems...

  • Senior Principal Systems Architect

    4 days ago

    Scottsdale, Arizona, United States General Dynamics Corporation Full time

    Job SummaryWe are seeking a highly skilled Senior Principal Systems Architect to join our team at General Dynamics Corporation. As a key member of our engineering team, you will be responsible for designing and developing advanced systems that meet the needs of our customers.Key ResponsibilitiesLead the development of system architectures and designs that...